CN113440193A - Composite absorbable interface screw and preparation method thereof - Google Patents
Composite absorbable interface screw and preparation method thereof Download PDFInfo
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- CN113440193A CN113440193A CN202110523210.9A CN202110523210A CN113440193A CN 113440193 A CN113440193 A CN 113440193A CN 202110523210 A CN202110523210 A CN 202110523210A CN 113440193 A CN113440193 A CN 113440193A
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- 239000002131 composite material Substances 0.000 title claims abstract description 67
- 238000002360 preparation method Methods 0.000 title description 6
- 229920000747 poly(lactic acid) Polymers 0.000 claims abstract description 33
- 239000004626 polylactic acid Substances 0.000 claims abstract description 33
- 229910052588 hydroxylapatite Inorganic materials 0.000 claims abstract description 32
- XYJRXVWERLGGKC-UHFFFAOYSA-D pentacalcium;hydroxide;triphosphate Chemical compound [OH-].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O XYJRXVWERLGGKC-UHFFFAOYSA-D 0.000 claims abstract description 32
- QORWJWZARLRLPR-UHFFFAOYSA-H tricalcium bis(phosphate) Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O QORWJWZARLRLPR-UHFFFAOYSA-H 0.000 claims abstract description 27
- 239000000203 mixture Substances 0.000 claims abstract description 10
- 238000000034 method Methods 0.000 claims abstract description 8
- 239000002245 particle Substances 0.000 claims description 23
- 238000001746 injection moulding Methods 0.000 claims description 20
- 238000002156 mixing Methods 0.000 claims description 17
- 238000001125 extrusion Methods 0.000 claims description 7
- 238000005469 granulation Methods 0.000 claims description 7
- 230000003179 granulation Effects 0.000 claims description 7
- 239000002994 raw material Substances 0.000 claims description 5
- 238000005485 electric heating Methods 0.000 claims description 4
- 238000010438 heat treatment Methods 0.000 claims description 4
- 238000002844 melting Methods 0.000 claims description 4
- 230000008018 melting Effects 0.000 claims description 4
- 238000012545 processing Methods 0.000 claims description 4
- 238000003860 storage Methods 0.000 claims description 4
- 238000005303 weighing Methods 0.000 claims description 4
- 239000000155 melt Substances 0.000 claims description 3
- 238000004519 manufacturing process Methods 0.000 claims 1
- JVTAAEKCZFNVCJ-UHFFFAOYSA-N lactic acid Chemical compound CC(O)C(O)=O JVTAAEKCZFNVCJ-UHFFFAOYSA-N 0.000 abstract description 28
- 239000004310 lactic acid Substances 0.000 abstract description 14
- 235000014655 lactic acid Nutrition 0.000 abstract description 14
- 239000000463 material Substances 0.000 abstract description 10
- 238000006731 degradation reaction Methods 0.000 abstract description 9
- 210000003041 ligament Anatomy 0.000 description 9
- 210000000988 bone and bone Anatomy 0.000 description 5
- 206010061218 Inflammation Diseases 0.000 description 4
- 239000004696 Poly ether ether ketone Substances 0.000 description 4
- 238000010521 absorption reaction Methods 0.000 description 4
- 230000015556 catabolic process Effects 0.000 description 4
- 230000004054 inflammatory process Effects 0.000 description 4
- 229920002530 polyetherether ketone Polymers 0.000 description 4
- 239000011148 porous material Substances 0.000 description 4
- 238000012360 testing method Methods 0.000 description 4
- 229910001069 Ti alloy Inorganic materials 0.000 description 3
- 238000009825 accumulation Methods 0.000 description 3
- 210000001264 anterior cruciate ligament Anatomy 0.000 description 3
- 230000006378 damage Effects 0.000 description 3
- 238000013461 design Methods 0.000 description 3
- 210000002967 posterior cruciate ligament Anatomy 0.000 description 3
- 230000007423 decrease Effects 0.000 description 2
- 230000007547 defect Effects 0.000 description 2
- 238000004090 dissolution Methods 0.000 description 2
- 238000009826 distribution Methods 0.000 description 2
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- IAYPIBMASNFSPL-UHFFFAOYSA-N Ethylene oxide Chemical compound C1CO1 IAYPIBMASNFSPL-UHFFFAOYSA-N 0.000 description 1
- 206010061223 Ligament injury Diseases 0.000 description 1
- 208000027418 Wounds and injury Diseases 0.000 description 1
- 239000000956 alloy Substances 0.000 description 1
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- 239000003795 chemical substances by application Substances 0.000 description 1
- 238000005520 cutting process Methods 0.000 description 1
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- 239000003814 drug Substances 0.000 description 1
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- 210000003127 knee Anatomy 0.000 description 1
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- 238000001000 micrograph Methods 0.000 description 1
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- 210000002303 tibia Anatomy 0.000 description 1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/064—Surgical staples, i.e. penetrating the tissue
- A61B17/0642—Surgical staples, i.e. penetrating the tissue for bones, e.g. for osteosynthesis or connecting tendon to bone
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/12—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
- A61L31/125—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix
- A61L31/127—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix containing fillers of phosphorus-containing inorganic materials
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/148—Materials at least partially resorbable by the body
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00526—Methods of manufacturing
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/064—Surgical staples, i.e. penetrating the tissue
- A61B2017/0649—Coils or spirals
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Abstract
The invention discloses a composite absorbable interface screw, which comprises a screw body, wherein the diameter of the head of the screw at the far end of the screw body is gradually reduced along the direction close to the far end; the outer surface of the screw body is provided with continuous threads; the central hole axially penetrates through the screw body, the section of the proximal end part of the central hole is hexagonal, the section of the distal end part of the central hole is circular, the diameter of the distal end part of the central hole is gradually reduced along the direction close to the distal end, and the inner surface of the distal end of the central hole is provided with a wedge-shaped part; the screw body is made of a mixture of polylactic acid, hydroxyapatite and beta-tricalcium phosphate. The invention ensures that the screw is not damaged due to overlarge torque when being implanted into a human body through the optimized selection on the structure; the method is realized by optimizing and selecting materials, and the influence of lactic acid on the pH value of the whole external environment in the whole degradation process is kept to be small.
Description
Technical Field
The invention relates to the technical field of medical equipment, in particular to a composite absorbable interface screw and a preparation method thereof.
Background
In the human knee, since the ligament may be torn or ruptured due to various accidents and accidents, those skilled in the related art have developed various technical means to repair or replace the damaged ligament. In particular, the Anterior Cruciate Ligament (ACL) and the Posterior Cruciate Ligament (PCL).
The interface screw is an important apparatus for treating anterior and posterior cruciate ligament injuries and reconstructing the cruciate ligament, and the specific operation is as follows: under an arthroscope, bone passages for fixing ligaments are drilled at the tibia and the femur of the knee joint respectively, the ligaments are extruded on the inner walls of the bone passages by using interface screws, and the ligaments grow on the bone passages finally after self-healing of a human body.
At present, interface screws on the market in China mainly comprise titanium alloy materials, and the interface screws made of polyether ether ketone (PEEK) materials begin to appear in 2019. However, the titanium alloy interface screw and the PEEK interface screw are retained in the human body for a long time or need to be taken out by a secondary operation after being implanted into the human body, thereby causing secondary damage to the patient.
Therefore, aiming at the defect that the existing interface screw needs to be subjected to secondary operation on a patient or is implanted into a human body for a long time to cause injury, the interface screw capable of being absorbed by the human body is developed, the technical purpose that the interface screw can be absorbed by the human body without secondary operation or products can not remain in the human body is achieved, and the technical problem to be solved urgently is solved.
Disclosure of Invention
The invention provides an interface screw capable of being absorbed by a human body, which aims to overcome the defect that the interior of the human body exists for a long time or the traditional titanium alloy and PEEK interface screw needs to be taken out for a secondary operation to cause secondary damage to the human body. Meanwhile, the interface screw structure is optimally designed, so that more excellent mechanical properties are realized.
A first aspect of the present invention provides a composite absorbable interface screw, comprising a screw body, a screw head at a distal end of the screw body having a diameter that gradually decreases in a direction toward the distal end; the outer surface of the screw body is provided with continuous threads; a central hole axially penetrates through the screw body, the section of the proximal end part of the central hole is hexagonal, the section of the distal end part of the central hole is circular, the diameter of the distal end part of the central hole is gradually reduced along the direction close to the distal end, and the inner surface of the distal end of the central hole is provided with a wedge-shaped part; the screw body is made of a composite material consisting of polylactic acid, hydroxyapatite and beta-tricalcium phosphate; the composite material comprises 60-80% of polylactic acid, 15-30% of hydroxyapatite and 5-20% of beta-tricalcium phosphate.
Preferably, the edge of the thread is provided with a circular arc chamfer.
Preferably, the diameter is constant from the proximal end of the screw body to the proximal end of the screw head.
Preferably, the distal end of the proximal portion of the central bore is located within the screw head.
Preferably, the polylactic acid has a number average molecular weight of 40 to 100 ten thousand.
Preferably, the particle size of the hydroxyapatite is 2-50 μm.
Preferably, the particle size of the beta-tricalcium phosphate is 60-500 meshes.
In a second aspect, a method for preparing the composite absorbable interface screw is provided, which comprises the following steps:
step S1, weighing polylactic acid, beta-tricalcium phosphate and hydroxyapatite according to the proportion, mixing the dried beta-tricalcium phosphate and the hydroxyapatite uniformly, adding the polylactic acid, and mixing uniformly to obtain a mixture;
step S2, sequentially carrying out melt blending and extrusion granulation on the mixture to obtain composite material particles;
and step S3, carrying out precision injection molding on the composite material particles as raw materials to obtain the composite absorbable interface screw.
Preferably, in step S2, the melt blending and the extrusion granulation are performed in a blender, the temperature of a melting zone is 160-220 ℃, and the rotation speed of a screw is 10-30 r/min.
Preferably, step S3 specifically includes the following steps:
step S31, adding the composite material particles into a storage tank of a micro screw type precision injection molding machine;
step S32, starting an electric heating system of the micro screw type precision injection molding machine, and setting the temperature to be 180-260 ℃;
step S33: and entering an injection molding processing link after the actual temperature of the micro screw type precision injection molding machine is consistent with the set temperature, injecting the molten composite material particles into a mold adopting a separated heating mode under the pressure of 210-300 bar, and maintaining the pressure and demolding to obtain the composite absorbable interface screw.
Compared with the prior art, the invention has the following technical effects:
(1) in the composite absorbable interface screw, most of the center holes with hexagonal sections penetrate through the screw body, namely, the hexagonal driving mode is adopted in the implanting process, so that the interface screw is prevented from being damaged by a screwdriver due to insufficient product strength. In addition, the screw head part which is consistently continued in the screw hexagonal driving mode almost penetrates through the whole screw body, the holding force of the screwdriver on the interface screw is greatly increased, and the screw is ensured not to be damaged due to overlarge torque when being implanted into a human body through the whole internal driving.
(2) The distal end of the central bore is provided with a wedge which effectively prevents the screw driver from penetrating from the tip of the interface screw and causing the screw to be damaged due to excessive axial insertion force of the user.
(3) On the material, the invention adopts three materials of polylactic acid, hydroxyapatite and beta-tricalcium phosphate to mix and modify the material, wherein the beta-tricalcium phosphate has high absorption rate in the degradation process in the early and middle period, generates pore channels, is beneficial to the dissolution of lactic acid and reduces the accumulation of lactic acid; meanwhile, due to the existence of the alkaline inorganic bone induction material hydroxyapatite, the problem of too fast degradation can be effectively solved, and the lactic acid is continuously neutralized in the middle and late stages, so that the influence of the lactic acid on the pH value of the whole external environment is small, and the inflammatory reaction of a patient is avoided in the whole degradation process.
(4) In the preparation of the composite absorbable interface screw, the three raw materials are mixed twice, and the mixing effect is more uniform compared with that of one-time mixing.
Drawings
FIG. 1a is a front view of a composite absorbable interface screw of the present invention;
FIG. 1b is a cross-sectional view of a composite absorbable interface screw of the present invention;
FIG. 1c is a left side view of a composite absorbable interface screw of the present invention;
FIG. 2 shows stress distribution of screws with three driving methods, wherein the left first is hexagonal, the left second is square, and the left third is pentagonal;
FIG. 3 composite absorbable interface screw
A torque map of (d);
FIG. 4 is a scanning electron microscope image of the pores generated in early and middle stages of in vitro degradation of the composite absorbable interface screw;
FIG. 5 is a graph of the in vitro degradation pH of a composite absorbable interface screw;
FIG. 6 is a schematic structural view of a composite absorbable interface screw of the present invention;
the symbols in the drawings indicate the description:
1-screw body, 12-screw head, 13-arc chamfer, 14-central hole, 15-wedge.
Detailed Description
In the present invention, distal means the end closest to or deepest within the patient's body, and proximal means the end farthest from or closest within the patient's body.
The structure of the composite absorbable interface screw provided by the invention is shown in figures 1a-1c and figure 6, and only comprises a screw body 1, wherein the diameter of a screw head 11 at the far end of the screw body 1 is gradually reduced along the direction close to the far end; the outer surface of the screw body 1 is provided with continuous threads 12; a central bore 14 extends axially through the screw body 1.
In the invention, because the interface screw is made of high polymer materials, the screw is broken by the screwdriver when the product is implanted into a human body due to insufficient product strength. To address the risk of screw failure, the hexagonal shape can be clearly determined to be more advantageous by analyzing the stress distribution of the screw for various drive types, as shown in fig. 2.
Thus, in a specific embodiment, as shown in fig. 1b-1c, the proximal portion of the central bore 14 is hexagonal in cross-section, and since the diameter from the proximal end of the screw body 1 to the proximal end of the screw head 11 is constant, and accordingly, the hexagonal cross-sectional area of the central bore 14 from the proximal end of the screw body 1 to the proximal end of the screw head 11 is constant, the cross-sectional area of the proximal portion of the central bore 14 in the screw head 11 decreases gradually in a direction approaching the distal end, and the distal end of the proximal portion of the central bore 14 is fixedly connected to the proximal end of the distal portion of the central bore 14.
Through the design, the hexagonal section design almost penetrates through the center hole 14, namely the screw head 11 with the hexagonal driving mode continuing consistently, the holding force of the screwdriver on the interface screw is greatly increased, and the screw is ensured not to be damaged due to overlarge torque when being implanted into a human body through the whole internal driving.
In one embodiment, the distal portion of the central bore 14 is circular in cross-section, the distal portion of the central bore 14 tapers in diameter in a direction proximal to the distal end, and the inner surface of the distal end of the central bore 14 is provided with a wedge 15. The design of the wedge 15 effectively prevents the screw from being broken due to the penetration of the driver from the interface screw tip due to excessive axial insertion force by the user.
In a preferred embodiment, the edge of the thread 12 is provided with a circular arc chamfer 13, and the shape has no sharp edge, so that the cutting of the thread to the ligament in the process of extruding the ligament by the screw is greatly reduced, and the tensile strength of the ligament is ensured.
In order to obtain an interface screw that can be absorbed by the human body without having to perform a secondary operation to remove it, the skilled person has made a lot of studies on the choice of materials for the absorbable interface screw, such as:
(1) pure polylactic acid, which is widely applied in the medical field, can be used for producing disposable transfusion tools, non-dismantling surgical sutures and the like, and low molecular polylactic acid is used as a drug sustained-release packaging agent and the like; if pure polylactic acid is applied to the face screw, the degradation is slow, and a large amount of lactic acid is generated in the middle and late stages, so that inflammatory reaction of a patient can be triggered.
(2) The polylactic acid/Hydroxyapatite (HA) composite material is characterized in that alkaline inorganic bone induction material hydroxyapatite is added to absorb generated lactic acid and induce the growth of osteocyte, but the HA absorption speed is slow, a pore channel cannot be formed, and the accumulation of lactic acid can trigger the generation of inflammatory reaction of a patient.
(3) The polylactic acid/beta-tricalcium phosphate (TCP) composite material is characterized in that beta-tricalcium phosphate is added to absorb produced lactic acid and induce the growth of osteocytes, but the absorption rate of TCP is too high, and lactic acid cannot be neutralized in middle and late stages, so that the development of the TCP composite material is limited.
In summary, the present invention provides a composite absorbable interface screw, which includes a screw body 1, wherein the screw body 1 is made of a composite material composed of polylactic acid, hydroxyapatite and β -tricalcium phosphate. During the degradation process of the beta-tricalcium phosphate in the early and middle stages, pore channels are generated, the dissolution of lactic acid is facilitated, the accumulation of the lactic acid is reduced, the continuous absorption of the lactic acid in the middle and later stages is ensured by adding the hydroxyapatite, so that the influence of the lactic acid on the pH value of the whole external environment is small (as shown in figure 5), and the inflammatory reaction of a patient is avoided in the whole degradation process.
In one embodiment, the composite material comprises, by mass, 60-80% of polylactic acid, 15-30% of hydroxyapatite and 5-20% of beta-tricalcium phosphate; more preferably, the composite material comprises 60-70% of polylactic acid, 25-30% of hydroxyapatite and 5-20% of beta-tricalcium phosphate.
Compared with beta-tricalcium phosphate, hydroxyapatite has better compatibility with polylactic acid, so that the higher the content of the hydroxyapatite is, the higher the extraction resistance is, and the higher the torque is.
In a preferred embodiment, the polylactic acid is L-polylactic acid (PLLA) having a number average molecular weight of 40 to 100 ten thousand; the particle size of the hydroxyapatite is 2-50 mu m, and the particle size of the beta-tricalcium phosphate is 60-500 meshes; the molecular weight of the absorbable interface screw after ethylene oxide sterilization is 10-30 ten thousand, and preferably 20 ten thousand.
In a second aspect, the invention further provides a preparation method of the composite absorbable interface screw, which comprises the following steps:
step S1, weighing polylactic acid, beta-tricalcium phosphate and hydroxyapatite according to the proportion, mixing the dried polylactic acid and hydroxyapatite uniformly, adding the polylactic acid, and mixing uniformly to obtain a mixture;
step S2, sequentially carrying out melt blending and extrusion granulation on the mixture to obtain composite material particles;
and step S3, carrying out precision injection molding by taking the composite material particles as raw materials to obtain the composite absorbable interface screw.
In a preferred embodiment, in step S2, the melt blending and extrusion granulation are performed in a blender, the temperature of the melting zone is 160-220 ℃, preferably 210 ℃, and the rotation speed of a screw is 10-30 rpm, preferably 30 rpm.
In a preferred embodiment, step S3 specifically includes the following steps:
step S31, adding the composite material particles into a storage tank of a micro screw type precision injection molding machine;
step S32, starting an electric heating system of the miniature screw type precision injection molding machine, setting the temperature to be 180-260 ℃, and preferably 240 ℃;
and S33, when the actual temperature and the set temperature of the micro screw type precision injection molding machine are consistent, entering an injection molding processing link, injecting the molten composite material particles into a mold adopting a separated heating mode under the pressure of 210-300 bar, preferably 250-300 bar, and maintaining the pressure and demolding to obtain the composite absorbable interface screw.
The present invention will be described in detail and specifically with reference to the following examples to facilitate better understanding of the present invention, but the following examples do not limit the scope of the present invention.
TABLE 1 The percentages by mass of L-polylactic acid, beta-tricalcium phosphate and hydroxyapatite in examples 1 to 4
| Examples | L-polylactic acid | Beta-tricalcium phosphate | Hydroxyapatite |
| Example 1 | 60％ | 10％ | 30％ |
| Example 2 | 65％ | 5％ | 30％ |
| Example 3 | 70％ | 5％ | 25％ |
| Example 4 | 80％ | 5％ | 15％ |
Example 1
The embodiment provides a preparation method of a composite absorbable interface screw, which comprises the following steps:
step S1, weighing the levorotatory polylactic acid, the beta-tricalcium phosphate and the hydroxyapatite according to the table 1, mixing the dried beta-tricalcium phosphate and the hydroxyapatite uniformly, adding the levorotatory polylactic acid, and mixing uniformly to obtain a mixture;
and step S2, sequentially carrying out melt blending and extrusion granulation on the mixture to obtain composite material particles: setting the temperature of a melting zone of the blender to 210 ℃ and the rotating speed of a screw to 30 revolutions per minute, then slowly pouring the mixture into a hopper to obtain a material rod, and granulating the extruded material rod to obtain composite material particles;
step S3, carrying out precision injection molding by taking the composite material particles as raw materials to obtain the composite absorbable interface screw:
step S31, adding the composite material particles into a storage tank of a micro screw type precision injection molding machine;
step S32, starting an electric heating system of the miniature screw type precision injection molding machine, and setting the temperature to be 240 ℃;
and S33, when the actual temperature and the set temperature of the micro screw type precision injection molding machine are consistent, entering an injection molding processing link, injecting the molten composite material particles into a mold adopting a separated heating mode under the pressure of 210-300 bar, and maintaining the pressure and demolding to obtain the composite absorbable interface screw.
Examples 2 to 4
A composite absorbable interface screw was prepared according to the ingredient percentages in table 1 and the method in example 1.
Performance testing
The composite absorbable interface screws prepared in examples 1-4 were subjected to screw pullout resistance force testing and torque testing:
table 2 examples 1-4 screw pullout force and torque test results
Thus, the composite absorbable interface screw of the present invention has a high pullout resistance (>480N), wherein the higher the content of hydroxyapatite, the greater the pullout resistance and the greater the torque, mainly due to the better compatibility of hydroxyapatite with polylactic acid relative to β -tricalcium phosphate.
The embodiments of the present invention have been described in detail, but the embodiments are merely examples, and the present invention is not limited to the embodiments described above. Any equivalent modifications and substitutions to those skilled in the art are also within the scope of the present invention. Accordingly, equivalent changes and modifications made without departing from the spirit and scope of the present invention should be covered by the present invention.
Claims (10)
1. A composite absorbable interface screw, characterized by comprising a screw body (1), wherein the screw head (11) at the far end of the screw body (1) is gradually reduced in diameter along the direction close to the far end; the outer surface of the screw body (1) is provided with continuous threads (12); a central hole (14) axially penetrates through the screw body (1), the section of the proximal end part of the central hole (14) is hexagonal, the section of the distal end part of the central hole (14) is circular, the diameter of the distal end part of the central hole (14) is gradually reduced along the direction close to the distal end, and the inner surface of the distal end of the central hole (14) is provided with a wedge part (15); the screw body (1) is made of a composite material consisting of polylactic acid, hydroxyapatite and beta-tricalcium phosphate, and the composite material comprises 60-80% of polylactic acid, 15-30% of hydroxyapatite and 5-20% of beta-tricalcium phosphate.
2. The composite absorbable interface screw of claim 1, wherein the edges of the thread (12) are provided with a radiused chamfer (13).
3. The composite absorbable interface screw of claim 1, wherein the diameter is constant from the proximal end of the screw body (1) to the proximal end of the screw head (11).
4. The composite absorbable interface screw of claim 1, wherein the distal end of the proximal portion of the central bore (14) is located within the screw head (11).
5. The composite absorbable interface screw of claim 1, wherein the polylactic acid is L-polylactic acid, and the number average molecular weight of the L-polylactic acid is 40-100 ten thousand.
6. The composite absorbable interface screw of claim 1, wherein the hydroxyapatite has a particle size of 2-50 μm.
7. The composite absorbable interface screw of claim 1, wherein the β -tricalcium phosphate has a particle size of 60-500 mesh.
8. A method of making a composite absorbable interface screw as claimed in any one of claims 1 to 7 comprising the steps of:
step S1, weighing polylactic acid, beta-tricalcium phosphate and hydroxyapatite according to the proportion, mixing the dried beta-tricalcium phosphate and the hydroxyapatite uniformly, adding the polylactic acid, and mixing uniformly to obtain a mixture;
step S2, sequentially carrying out melt blending and extrusion granulation on the mixture to obtain composite material particles;
and step S3, carrying out precision injection molding on the composite material particles as raw materials to obtain the composite absorbable interface screw.
9. The method for preparing the composite absorbable interface screw according to claim 8, wherein in step S2, the melt blending and the extrusion granulation are performed in a blender, the temperature of the melting zone is 160-220 ℃, and the screw rotation speed is 10-30 rpm.
10. The method for preparing a composite absorbable interface screw of claim 8, wherein step S3 comprises the following steps:
step S31, adding the composite material particles into a storage tank of a micro screw type precision injection molding machine;
step S32, starting an electric heating system of the micro screw type precision injection molding machine, and setting the temperature to be 180-260 ℃;
and S33, when the actual temperature of the micro screw type precision injection molding machine is consistent with the set temperature, entering an injection molding processing link, injecting the molten composite material particles into a mold adopting a separated heating mode under the pressure of 210-300 bar, and maintaining the pressure and demolding to obtain the composite absorbable interface screw.
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